• Execute and coordinate decentralized, fully remote clinical research activities across autoimmune studies. • Own day-to‑day remote member operations—from recruitment and e‑consent to virtual follow‑up and remote data collection. • Ensure protocol adherence and high‑quality real‑world data. • Monitor protocol adherence and visit windows using remote tracking tools; document adverse events and concomitant medications based on member reports and records. • Maintain accurate and complete electronic study documentation, including source notes, case report forms, and digital regulatory binders. • Support IRB submissions, amendments, and continuing reviews with remotely managed documents, reports, and member‑facing materials. • Collaborate virtually with data, product, and operations teams to troubleshoot remote workflows and ensure data quality in decentralized studies.

• Support Medical Monitor or serve as clinical lead of a phase 1a/1b study and future late-stage studies, including contributing to/overseeing study start-up, enrollment, study medical monitoring, data cleaning, and CSR writing • Partner with investigators and CROs to design and implement clinical studies, respectively • Write protocols, investigator brochures, and clinical study reports, and review clinical trial documents • Conduct investigator meetings and safety review committee meetings and lead site initiation visits with clinical trial investigators • Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets • Translate findings from research and non-clinical studies into clinical development opportunities • Interact with clinical investigators and thought leaders • Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines.

• Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Biostatistics, and Regulatory Affairs, to design scientifically rigorous late stage clinical trials. • Contribute to the development of study protocols, investigator brochures, informed consent forms, and other essential study documents. • Provide scientific input for trial endpoints, patient populations, and statistical analyses. • Act as the scientific lead for assigned late stage studies, ensuring adherence to clinical trial protocols and regulatory requirements. • Provide ongoing scientific and clinical input during trial execution, including participation in investigator meetings, site initiation visits, study monitoring activities, and medical data review. • Review and interpret clinical trial data, ensuring consistency and alignment with study objectives. • Address protocol-related questions from investigators and site staff. • Contribute to the preparation of regulatory submissions, including clinical study reports (CSRs) and documentation for Investigational New Drug (IND) and New Drug Application (NDA) filings. • Ensure clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory standards. • Collaborate with the Biostatistics and Data Management teams to review and interpret study data, ensuring accuracy and completeness. • Participate in the preparation of abstracts, presentations, clinical study reports, and manuscripts for scientific meetings and publications. • Partner with cross functional team members to develop and execute clinical development strategies. • Serve as a subject matter expert within the clinical team, providing scientific insights to support decision-making.

• Upfront support of Medical Device clinical trials and research, supporting statistical aspects of study design by assisting with sample size calculation via power analysis and study design, and ensuring the protocol and variables collected support the endpoint analysis. • Execute statistical analyses including, but not limited to, established methods such as confidence interval testing, regression models, Bayesian methods, missing data handling, mixed models. • Create reproducible code, summary tables, visualizations, and written statistical outputs that support study reports, technical documents, and defend results to regulatory agencies. • Prepare analysis datasets by performing data cleaning, validation, formatting, and code reviews. • Document statistical approaches and analytical workflows to promote transparency and reproducibility to be documented in the Clinical History File. • Collaborate with cross‑functional partners including Clinical Operations, Quality and Regulatory, engineering, and data management teams to support project execution.